This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Given IV

Other Names:

ABI 007

ABI-007

Abraxane

Other: Laboratory Biomarker Analysis

Correlative studies

Detailed Description:

OBJECTIVES:

I. Estimate the antitumor activity of ABI-007 in patients with persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix who have failed on higher-priority treatment protocols.

II. Determine the nature and degree of toxicity of ABI-007 in this cohort of patients.

III. To determine the expression of the SPARC (secreted protein, acidic and rich in cysteine) protein in the tumor tissue and plasma (exploratory study) of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study for SPARC protein expression analysis by ELISA. Archived tumor tissue samples are also analyzed.

After completion of study treatment, patients are followed periodically for up to 5 years.

Eligibility

Ages Eligible for Study:

Child, Adult, Senior

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression

Histologic confirmation of the original primary tumor

Measurable disease, defined as at least one target lesion that can be accurately measured in at least one dimension ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, or ≥ 10 mm when measured by spiral CT scan

Tumors within a previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy

Must have received 1 prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or nonsquamous cell carcinoma of the cervix

Chemotherapy administered as a radiosensitizer is not a systemic chemotherapy regimen

Not eligible for a higher priority GOG protocol

GOG performance status 0, 1, or 2

No active infection requiring antibiotics

Platelet count ≥ 100,000/mm^3

Absolute neutrophil count ≥ 1,500/mm^3

Creatinine ≤ 1.5 times upper limit of normal (ULN)

Bilirubin ≤ 1.5 times ULN

SGOT and alkaline phosphatase ≤ 2.5 times ULN

No neuropathy (sensory and motor) > grade 1

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

No evidence of any other invasive malignancies within the past 3-5 years, except localized breast cancer, head and neck cancer, cervical cancer, or nonmelanoma skin cancer

No pre-existing hearing loss/tinnitus > grade 1

No concurrent amifostine or other protective agents

Recovered from effects of prior surgery, radiotherapy, or chemotherapy

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00309959